← FDA DRUG APPROVALS

FDA ANDA · ANDA062912

VANCOMYCIN HYDROCHLORIDE

Sponsor: HOSPIRA

APPLICATION
ANDA062912
TYPE
ANDA
ORIGINAL APPROVAL
1988-08-04
LATEST ACTION
2021-05-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 750MG BASE/VIAL · INJECTABLE · INJECTION
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 1.5GM BASE/VIAL · INJECTABLE · INJECTION
VANCOMYCIN HYDROCHLORIDEPrescription
VANCOMYCIN HYDROCHLORIDE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2021-05-24Labeling · Supplement 81 · standardAP
2020-09-01Labeling · Supplement 74 · standardAP
2020-09-01Labeling · Supplement 52 · standardAP
2017-04-13Labeling · Supplement 58 · standardAP
2012-06-12Labeling · Supplement 49 — Label ↗AP
2011-11-30Labeling · Supplement 40 — Label ↗AP
2009-01-07Labeling · Supplement 39 — Letter ↗AP
2009-01-07Manufacturing (CMC) · Supplement 38 — Letter ↗AP
2008-08-21Labeling · Supplement 16AP
2002-10-04Manufacturing (CMC) · Supplement 11AP
2002-02-01Manufacturing (CMC) · Supplement 10AP
2001-06-14Manufacturing (CMC) · Supplement 9AP
2000-07-14Manufacturing (CMC) · Supplement 8AP
1996-11-13Manufacturing (CMC) · Supplement 7AP
1993-10-22Manufacturing (CMC) · Supplement 5AP
1991-07-23Manufacturing (CMC) · Supplement 4AP
1988-12-05Manufacturing (CMC) · Supplement 2AP
1988-12-05Manufacturing (CMC) · Supplement 1AP
1988-08-04OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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